Advance G52361Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10827002523613), received between Dec 9, 2016 and Apr 19, 2022 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING A 60% OCCLUDED LESION IN THE ARM, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON THE FIRST INFLATION. A 5 FRENCH COOK SHEATH WAS USED DURING THE PROCEDURE. A 50:50 RATIO OF CONTRAST TO SALINE WAS USED TO INFLATE THE BALLOON, USING AN UNKNOWN INFLATION DEVICE; HOWEVER, THE BALLOON RUPTURED PRIOR TO REACHING NOMINAL PRESSURE. THE VESSELS WERE NOT TORTUOUS OR CALCIFIED. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON WAS REMOVED BY ITSELF. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142416 ↗
• InjuryJan 27, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE COMMON ILIAC ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY UPON FIRST INFLATION AT 5 ATMOSPHERES. THE DEVICE WAS UNABLE TO BE REMOVED, AND THE BALLOON APPEARED TO BE "SNAPPED." THE PROXIMAL SEGMENT OF THE BALLOON REMAINED IN THE PATIENT AND THE DISTAL SEGMENT WAS IN THE 6FR SHEATH. THE PROXIMAL PORTION OF THE BALLOON WAS VISUALIZED IN THE VESSEL WALL UNDER ULTRASOUND AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). AFTER CONSULTATION WITH VASCULAR SURGERY, THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WHERE THE RETAINED SEGMENT WAS SUCCESSFULLY REMOVED FROM THE COMMON FEMORAL ARTERY. VISIPAQUE 270 CONTRAST WAS USED WITH A 1 TO 1 RATIO OF CONTRAST TO SALINE. MODERATE CALCIFICATION WAS REPORTED BUT NO ANGULATION OR VESSEL TORTUOSITY WERE REPORTED. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13365959 ↗
• MalfunctionApr 12, 2021Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654057 ↗
• MalfunctionApr 9, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640808 ↗
• MalfunctionApr 9, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640784 ↗
• MalfunctionDec 16, 2020Material Separation; Material Separation

  AS REPORTED, DURING AN UPPER LIMB FISTULOPLASTY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER SEPARATED. AN UNKNOWN WIRE GUIDE AND INFLATION DEVICE WERE USED DURING THE PROCEDURE, AS WELL AS ANOTHER MANUFACTURER'S 5 FRENCH SHEATH. AS THE DEVICE WAS BEING REMOVED, POST DILATION, THE CATHETER SEPARATED, LEAVING THE DISTAL SECTION WITH THE DEFLATED BALLOON OVER THE WIRE GUIDE, INSIDE THE SHEATH. THE WIRE AND SHEATH, WITH THE DEVICE FRAGMENT INSIDE, WERE WITHDRAWN FROM THE PATIENT. A NEW SHEATH WAS THEN INSERTED AND THE PROCEDURE WAS COMPLETED. FLUOROSCOPY AND VISUAL INSPECTION CONFIRMED THAT NOTHING WAS LEFT IN THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11018426 ↗
• MalfunctionApr 7, 2020Material Puncture/Hole; Material Puncture/Hole

  ADDITIONAL INFORMATION WAS RECEIVED 07APR2020. A 5 OR 6 FRENCH COOK FLEXOR SHEATH WAS USED DURING THE PROCEDURE. AN UNKNOWN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME, USING A "NON-IONIC" 1:1 CONTRAST TO SALINE SOLUTION, TO THE RECOMMENDED INFLATION PRESSURE. THE USER ALSO REPORTED THAT THE BALLOON WAS NOT ABLE TO BE INFLATED. THE BALLOON, WHICH WAS NOT INFLATED WITHIN A STENT, WAS REMOVED BY ITSELF. AS THE DEVICE WAS NOT USED WITHIN THE VASCULAR SYSTEM, BLOOD WAS NOT OBSERVED IN THE INFLATION DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933417 ↗
• MalfunctionApr 12, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE (PTA), THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WOULD NOT INFLATE PRIOR TO PLACEMENT IN THE PATIENT'S VASCULATURE. A SECOND ADVANCE 35 LP LOW PROFILE BALLOON CATHETER FROM THE SAME LOT WAS PREPARED AND, IT TOO WOULD NOT INFLATE. THE BALLOON PRESSURE WAS REPORTED TO BE 6 ATMOSPHERES (ATM) AND A NORMAL SALINE AND CONTRAST 1:1 MIX WAS USED. BECAUSE THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS INFLATED OUTSIDE OF THE PATIENT'S VASCULATURE, IT DID NOT COME IN CONTACT WITH THE LESION. ANOTHER MANUFACTURER'S BALLOON CATHETER WAS SUCCESSFULLY PREPARED AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7427210 ↗
• MalfunctionJan 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING FISTULA TREATMENT OF A LESION LOCATED IN THE PATIENT'S ARM, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BALLOON RUPTURED UPON THE THIRD INFLATION AT 15 ATMOSPHERE (ATM). ANOTHER BALLOON CATHETER WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7178337 ↗
• InjuryMar 22, 2017Material Rupture; Material Rupture

  DURING A FISTULOGRAM PROCEDURE THE ADVANCE 35 LP LOW PROFILE BALLOON WAS PLACED THROUGH TIGHT STENOSIS IN THE AXILLARY VEIN. UPON PLACEMENT, THE BALLOON WAS INFLATED AND CONSEQUENTLY, RUPTURED CIRCUMFERENTIALLY. UPON WITHDRAWING THE DEVICE, A PORTION OF THE BALLOON REMAINED IN THE PATIENT. ATTEMPTS WERE MADE TO REMOVE BALLOON FRAGMENTS, BUT THESE ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO REMOVE THE BALLOON FRAGMENTS THROUGH AN OPEN PROCEDURE OCCURRING (B)(6) 2017. PHYSICIAN WAS UNCONCERNED WITH MIGRATION OF THE FRAGMENTED BALLOON DUE TO THROMBUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED ABOUT THE PATIENT'S CONDITION AFTER SURGERY, HOWEVER, NO INFORMATION HAS BEEN RETURNED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 6424026 ↗
• InjuryDec 12, 2016Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED A BALLOON WAS BEING USED TO POST DILATE AN ILIAC STENT IN A HEAVILY CALCIFIED VESSEL WHEN THE BALLOON RUPTURED CIRCUMFERENTIALLY (MDR # 1820334-2016-01467). DURING ATTEMPTS TO RETRIEVE THE DISTAL SECTION OF THE BALLOON THE TIP OF THE CATHETER SEPARATED FROM THE PROXIMAL SECTION AND REMAINED INSIDE THE PATIENT. AN ATTEMPT WAS MADE TO TRY AND SNARE THE SECTION REMAINING BUT WAS UNSUCCESSFUL. (MDR # 1820334-2016-01468, SUBJECT OF THIS REPORT). THE DECISION WAS MADE TO LEAVE THE BALLOON FRAGMENT IN PLACE AND STENT OVER IT. A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY AND AN ADDITIONAL ILIAC STENT WAS NEEDED ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6165910 ↗
• InjuryDec 12, 2016Material Rupture; Material Rupture

  IT WAS REPORTED A BALLOON WAS BEING USED TO POST DILATE AN ILIAC STENT IN A HEAVILY CALCIFIED VESSEL WHEN THE BALLOON RUPTURED CIRCUMFERENTIALLY (MDR # 1820334-2016-01467 SUBJECT OF THIS REPORT) DURING ATTEMPTS TO RETRIEVE THE DISTAL SECTION OF THE BALLOON, THE TIP OF THE CATHETER SEPARATED FROM THE PROXIMAL SECTION AND REMAINED INSIDE THE PATIENT. AN ATTEMPT WAS MADE TO TRY AND SNARE THE SECTION REMAINING BUT WAS UNSUCCESSFUL. (MDR # 1820334-2016-01468) THE DECISION WAS MADE TO LEAVE THE BALLOON FRAGMENT IN PLACE AND STENT OVER IT. A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY AND AN ADDITIONAL ILIAC STENT WAS NEEDED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6165858 ↗
• InjuryDec 9, 2016Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ILIAC ANGIOPLASTY PROCEDURE ON AN (B)(6) MALE PATIENT, AFTER INFLATION OF THE BALLOON THE PHYSICIAN HAD DIFFICULTY REMOVING THE BALLOON AND IT BROKE DURING RETRIEVAL ATTEMPTS. A GOOSENECK WAS USED TO REMOVE THE BALLOON. IT IS UNCLEAR IF AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE BALLOON OR IF IT WAS REMOVED DURING THE SCHEDULED ANGIOPLASTY PROCEDURE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6157881 ↗